RX Product News

Abilify

May 8, 2008?The FDA approved updated labeling for Abilify (aripiprazole) as an adjunctive therapy to either lithium or valproate for the acute treatment of manic and mixed episodes associated with bipolar I disorder with or without psychotic features in adults. Abilify has been approved as monotherapy for the treatment of manic and mixed episodes associated with bipolar I disorder with or without psychotic features in adults since September 2004. In addition to this new indication, the FDA approved a new recommended starting and target dose of 15 mg daily for Abilify monotherapy in the treatment of bipolar I disorder in adults.

Actonel

April 24, 2008?The FDA approved a new once-a-month dose (150 mg) of Actonel (risedronate
sodium) tablets for the treatment and prevention of
postmenopausal osteoporosis. Actonel is a bisphosphonate
approved to reduce the risk of fractures in
postmenopausal women with osteoporosis. It also is
indicated for treatment to increase bone mass in men
with osteoporosis, treatment and prevention of glucocorticoid-
induced osteoporosis, and treatment of
Paget?s disease. With this approval, Actonel is the first
and only monthly option approved to protect women
from fracture at both the spine and sites beyond the
spine.

April 29, 2008?Sucampo Pharmaceuticals Inc and
Takeda Pharmaceutical Co Ltd and its wholly owned
subsidiary, Takeda Pharmaceuticals North America
Inc, announced that the FDA approved Sucampo?s
supplemental New Drug Application for Amitiza (lubiprostone)
8-?g capsules twice daily to treat irritable
bowel syndrome with constipation in women aged 18
years or older. Amitiza, a chloride channel activator,
received FDA approval in January 2006 and has been
available since April 2006 as a therapy for chronic
idiopathic constipation in adults.

Ferralet 90

Marketed by:

Mission Pharmacal Co
(San Antonio, TX)

Indication:

May 20, 2008?Mission
Pharmacal announced the
launch of Ferralet 90, a new
prescription oral iron supplement
for the treatment of iron
deficiency anemia (IDA) that is
responsive to oral iron therapy.
IDA is a depletion of stored
iron that prevents maturation
of red blood cells. Ferralet 90
contains 90 mg of carbonyl
iron as well as essential vitamins and minerals to help
patients replenish iron stores in a safe, effective, and
tolerable manner. Iron deficiency is the most common
nutritional deficiency and the leading cause of
anemia in the United States.

Lacrisert

Marketed by:

Aton Pharma Inc
(Lawrenceville, NJ)

Indication:

April 23, 2008?Aton Pharma Inc announced that it launched an expanded distribution program that incorporates sampling, reimbursement assistance, and patient education resources for the dry eye medication Lacrisert (hydroxypropyl cellulose ophthalmic insert). Lacrisert is a preservative-free, once-daily, sustained-release prescription insert that helps to retain moisture, stabilize the tear film, and lubricate the eye. Lacrisert has newly designed packaging, as well as a new national drug code. Lacrisert is administered into the inferior cul-de-sac of the eye beneath the base of the tarsus. It should not be placed in apposition to the cornea, nor beneath the eyelid at the level of the tarsal plate. Illustrated instructions are included in each package.

Dosage Form:

Ophthalmic insert: 5 mg supplied in packages of 60 sterile unit doses (each wrapped in an aluminum blister), 2 reusable applicators, and a plastic storage container to store the applicators after use

Seroquel

Marketed by:

AstraZeneca
(Wilmington, DE)

Indication:

May 14, 2008?AstraZeneca announced that the FDA approved Seroquel (quetiapine fumarate tablets) for the maintenance treatment of patients with bipolar I disorder, as adjunct therapy to lithium or divalproex. Seroquel is approved by the FDA for the treatment of schizophrenia, and it also is the only single agent approved by the FDA for the treatment of both depressive episodes in bipolar disorder and acute manic episodes associated with bipolar I disorder. Bipolar disorder currently affects approximately 8 million US adults and is considered one of the most severe forms of mental illness.

Hot Rx

NovoSeven RT

Marketed by:

Novo Nordisk
(Princeton, NJ)

Indication:

May 13, 2008?Novo Nordisk announced that the FDA approved NovoSeven RT (coagulation factor VIIa [recombinant] room temperature stable), the first room temperature?stable recombinant product available for the treatment of bleeding episodes in patients with hemophilia with inhibitors. NovoSeven RT is a new formulation of NovoSeven (coagulation factor VIIa [recombinant]) designed to provide patients with added flexibility when treating their condition. This new formulation
does not need refrigeration and can be moved in and out of the refrigerator. In addition, NovoSeven RT has a higher concentration for lower infusion volumes and quick administration.

Vyvanse

Marketed by:

Shire plc
(Philadelphia, PA)

Indication:

April 23, 2008?Shire plc announced that it received FDA approval for Vyvanse (lisdexamfetamine dimesylate), for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults. Vyvanse was originally approved in July 2007 for the
treatment of ADHD in children aged 6 to 12 years and is now the first and only once-daily prodrug stimulant approved to treat adults with ADHD. The recommended dosage for adults and pediatric patients aged 6 to 12 is 30 mg once daily in the morning; the maximum dose is 70 mg once daily in the morning. ADHD is one of the most common psychiatric disorders in children and adolescents and also affects an estimated 4.4% of US adults aged 18 to 44 based on results from the National Comorbidity Survey Replication.

Dosage Form:

Tablets: 20, 30 40, 50, 60, and 70 mg (dosage strengths of 20, 40, and 60 mg are expected to be available in pharmacies this summer)